Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

Completed

• Conditions: Insomnia
• Interventions: Drug: Ramelteon

• Registration Number: NCT02058992
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.

Detailed Description

This is a drug use surveillance planned to examine the safety and efficacy of ramelteon tablets when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia (planned sample size, 3000)

The usual adult dosage is 8 mg of ramelteon administered orally once daily at bedtime.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-11
• Results First Submitted: 2015-12-07
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-02
• Last Update Submitted: 2016-06-02
• Results First Posted: 2016-07-14
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3339

Inclusion Criteria

1. Sleep-onset difficulty associated with insomnia

Exclusion Criteria

1. Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets
2. Patients with severe liver dysfunction
3. Patients taking fluvoxamine maleate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ramelteon 8 mg administered orally once daily	Ramelteon	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting One or More Adverse Drug Reactions	Baseline up to 6 weeks	Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Number of Participants Reporting One or More Serious Adverse Drug Reactions	Baseline up to 6 weeks	Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary Outcome Measures

Name	Time	Method
Sleep Status: Total Sleep Time	Baseline and Week 4	Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode.
Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4	Week 4	PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition.
Sleep Status: Number of Awakenings	Baseline and Week 4	Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation.
Sleep Status: Sleep Onset Latency	Baseline and Week 4	Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset.